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Z-Res Zionic Pro Max Hp
EUDAMEDClass IIb (EU MDR)
Ref A497Model Z-RES ZIONIC PRO MAX HP
Identity
- Device Name
- Z-RES ZIONIC PRO MAX HP EUDAMED
- Model / Reference
- Z-RES ZIONIC PRO MAX HP EUDAMEDA497 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436601291486 EUDAMED
- Basic UDI-DI
- 843660129ZPRESHP6J EUDAMED
- EMDN Code
- Z12040203 DERMAL REGENERATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Z-Res Zionic Pro Max Hp by Termosalud, S.L. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 843660129ZPRESHP6J | Class IIb | Active |
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Manufacturer
- Manufacturer
- Termosalud, S.L.
- EUDAMED SRN
- ES-MF-000019177
Sources (1)
- EUDAMED 8d8705be-aa95-4192-9838-c7194f1762b3 61 fields · synced Jun 18, 2026